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临床试验/NCT06105840
NCT06105840Enrolling By Invitation1 期

Effect of Combination of Curcuminoid Standardized Turmeric Extract With Acupressure on Inflammatory Markers, Endorphins and Quality of Life in Elderly People With Osteoarthritis Genu

Gadjah Mada University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年8月27日最近更新:
适应症

试验速览

阶段
1 期
状态
Enrolling By Invitation
发起方
入组人数
70
试验地点
1
主要终点
Inflammation Marker

研究概览

简要总结

The goal of this clinical trial is to to investigate the efficacy of acupressure and standardized curcuminoids from turmeric extract to inflammatory markers, endorphin hormones in the blood and quality of life in elderly patient with Osteoarthritis Genu.

The main questions it aims to answer are:

  1. Is there any effect combination of acupressure and standardized curcuminoids from turmeric extract to inflammatory markers in elderly patients with Osteoarthritis Genu?
  2. Is there any effect combination of acupressure and standardized curcuminoids from turmeric extract to endorphin hormones in the blood in elderly patients with Osteoarthritis Genu?
  3. Is there an effect combination of acupressure and standardized curcuminoids from turmeric extract to quality of life in elderly patients with Osteoarthritis Genu?

Participants in the intervention group received 2 treatments, namely acupressure at points that provide osteoarthritis-specific comfort and standardized curcuminoids from turmeric extract capsules. Participant in the control group alo would receive 2 treatments, an active placebo (starch capsules and sham acupressure).

Researchers will compare interventional group and sham group to see efficacy the combination therapy

详细描述

Background. One of the degeneration processes that occurs in the elderly is the musculoskeletal system. These deteriorations include bone loss and a decrease in joint fluid volume which is exacerbated by bearing the weight of the body. Pain in Osteoarthritis patients affects many areas of quality of life such as physical function, emotional behavior, and mental health. Osteoarthritis-related pain is a major factor in poor quality of life. The most common pharmacological treatment to control pain is the use of non-steroidal anti-inflammatory drugs (NSAIDs), but these drugs carry the risk of causing side effects. Limitations associated with pharmacologic treatment result in patients choosing commonly available alternative therapies for pain management. Popular alternative therapies include herbal therapy, therapeutic touch, relaxation techniques, music therapy, acupuncture, and acupressure. This alternative therapy, unlike the use of drugs, does not produce dangerous side effects.

Research on the effectiveness of herbal therapy on inflammatory osteoarthritis patients was conducted in Indonesia in 2009 on 80 sufferers with the result that administration of turmeric rhizome extract curcuminoids significantly suppressed the activity of synovial fluid monocytes to secrete Cyclooxygenase-2 (COX-2) and Reactive Oxygen Intermediate (ROI), reduced leukocyte numbers and fluid Malondialdehyde (MDA) levels. synovia and reduces Osteoarthritis (OA) joint pain, with an ability that is not significantly different compared to diclofenac sodium therapy 3x25 mg per day. Furthermore, the development of herbal therapy for Osteoathritis continued with research which proved that the combination of ginger, ginger, soybean and shrimp shell extracts provided significant results in reducing joint pain, stiffness and physical disability which were evaluated based on the Western Ontario and McMaster values. Universities Osteoarthritis Index (WOMAC) and did not show a significant difference when compared with meloxicam.

Research that has been carried out to evaluate the effectiveness of acupressure therapy for the pain of Osteoarthritis patients was also carried out in several countries, including by study on 40 Osteoarthritis patients who were divided into two groups (intervention and control). In the intervention group, acupressure therapy was given for 5 days with a duration of 30 minutes each time. The results showed that the average pain score in the intervention group decreased significantly from 5.89 at the beginning of the study to 4.11 at the end of the study, while the pain score did not change substantially in the control group. These findings remained consistent after adjusting for age, weight, and pretreatment covariates. This study supports the evidence that Acupressure therapy provides an effective option for short-term knee pain relief in patients with knee Osteoarthritis. In line with the results, there was research which was conducted on 51 elderly with osteoarthritis divided into 3 groups (acupressure intervention, placebo and control). This study revealed that respondents who received acupressure therapy for 3-4 weeks with the duration of each therapy being 10-15 minutes, showed a significant reduction in the total WOMAC index, pain and physical dysfunction.

So far, there has been no research combining standardized curcuminoid turmeric extract therapy with acupressure for inflammation and pain in osteoarthritis patients. More clinical trials with appropriate methodology are needed to confirm the effectiveness of standardized turmeric extract, curcuminoids and acupressure to treat physical problems in osteoarthritis patients.

Study Design/Methods. The research will be carried out by design Randomized Controlled Trials (RCT). Respondents will be divided randomly into 2 groups, namely treatment and control. The treatment group will receive interventions, namely herbal therapy and acupressure therapy, while the control group will receive active placebo (capsules containing starch and acupressure massage at points that are not to provide comfort for knee pain). In this study, a double blind technique was used , that is, the subjects and researchers did not know which respondents were in the treatment group and which respondents were in the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The inclusion criteria in this study are:
  • Clinical diagnosis of osteoarthritis which confirmed by physical examination and x-rays
  • Experience pain with a Numeric Rating scale of 1-7
  • Must be able to swallow capsules
  • Must be able to carry out mobility without assistance or with minimal assistance

排除标准

  • in this study are:
  • Parkinson's disease
  • Dementia disease
  • Psychosis disease
  • New bone fractures
  • Joint dislocations
  • Rheumatic diseases other than osteoarthritis (rheumatoid arthritis)
  • Undergoing joint replacement therapy.
  • Analgesic dependent disease

结局指标

主要结局

Inflammation Marker

时间窗: Outcome measurements will be carried out before starting therapy and after 3 weeks of therapy

Inflammation markers are carried out by measuring Leukocyte Number, NLR, Blood Sediment Rate and COX-2 hormone. Outcome measurements will be carried out a complete blood test using a Hematology Analyzer. Leukocyte numbers measured in microliter (mcL). Neutrophil-Lymphocyte Count Ratio can be calculated from the number of neutrophils (cells) and lymphocytes (cells). Neutrophils and lymphocytes will be combined to report Neutrophil-Lymphocyte Count Ratio in %. Blood Sediment Rate is a measurement of the difference in the decrease in height of red blood cells in a test tube (mm) divided by the time (hours) required for all of them to settle to the bottom of the test tube. There will be combined to report Blood Sediment Rate in mm/hr. The COX-2 hormone examination was carried out using the Enzyme Linked Immunosorbent Assay (ELISA). The amount of COX-2 Hormone in the blood in nanograms and blood sample volume in milliliters will be combined to report secretion of COX-2 in ng/mL

Endorphin Hormones

时间窗: Outcome measurements will be carried out before starting therapy and after 3 weeks of therapy

Secretion of endorphin hormones Endorphins, in this case beta endorphin, are hormones released by the pituitary gland in response to stress or pain, which are also secreted in blood plasma. Endorphin hormone examination is carried out using the Enzyme Linked Immunosorbent Assay (ELISA) method on blood plasma. The amount of Endorphin Hormone in the blood in nanograms and the blood sample volume in milliliters will be combined to report secretion of COX-2 in ng/mL

次要结局

未报告次要终点

研究者

发起方
Gadjah Mada University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Srinalesti Mahanani

Principal Investigator

Gadjah Mada University

研究点 (1)

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